Trial Outcomes & Findings for Quartet Lead and Resynchronization Therapy Options III (QUARTO_III) (NCT NCT02476201)
NCT ID: NCT02476201
Last Updated: 2022-03-02
Results Overview
The number of CRT responders was evaluated at 6 months post-implant. A CRT responder patient was a patient with an improvement of \>15 % in LVESV, as measured by echocardiography.
COMPLETED
NA
105 participants
6 months
2022-03-02
Participant Flow
Subject enrollment began on 11-Feb-2016 and the last enrollment occurred on 13-Aug-2018.
Participant milestones
| Measure |
MPP ON
Patients implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead will be programmed with the MultiPoint Pacing (MPP) feature activated.
|
|---|---|
|
Overall Study
STARTED
|
105
|
|
Overall Study
Implant Attempts
|
103
|
|
Overall Study
Sucessful Implants
|
102
|
|
Overall Study
6 Months Visit
|
82
|
|
Overall Study
COMPLETED
|
79
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
MPP ON
Patients implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead will be programmed with the MultiPoint Pacing (MPP) feature activated.
|
|---|---|
|
Overall Study
Unable to program MPP
|
9
|
|
Overall Study
Study echo not performed
|
5
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
MPP programmed to OFF
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Unsuccessful implant
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MPP ON
n=105 Participants
MPP ON: Subjects implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
|
|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 8.4 • n=105 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=105 Participants
|
|
Region of Enrollment
Spain
|
97 participants
n=105 Participants
|
|
Region of Enrollment
Portugal
|
8 participants
n=105 Participants
|
|
Left Ventricular End Systolic Volume (LVESV)
|
127.78 mililiters
STANDARD_DEVIATION 48.87 • n=77 Participants • The number of subjects in this analysis population differs from the overall study population because LVESV was only calculated in the 77 analyzable subjects with 6-month echocardiogram data available.
|
|
New York Heart Association (NYHA) Classification
NYHA I
|
6 Participants
n=105 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA II
|
60 Participants
n=105 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA III
|
39 Participants
n=105 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA IV
|
0 Participants
n=105 Participants
|
|
Cardiomyopathy Etiology
Non-ischemic
|
61 Participants
n=105 Participants
|
|
Cardiomyopathy Etiology
Ischemic
|
44 Participants
n=105 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis population included subjects implanted with a Quartet LV quadripolar lead and with the MPP feature activated and who had a 6-month CRT response evaluation via echocardiography. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit, or had relevant 6-month data missing were excluded from the analysis.
The number of CRT responders was evaluated at 6 months post-implant. A CRT responder patient was a patient with an improvement of \>15 % in LVESV, as measured by echocardiography.
Outcome measures
| Measure |
MPP ON
n=79 Participants
MPP ON: Subjects implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
|
|---|---|
|
Number of CRT Responders
|
53 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The analysis population included subjects implanted with a Quartet LV quadripolar lead and with the MPP feature activated and who had a 6-month CRT response evaluation via echocardiography. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit, or had relevant 6-month data missing were excluded from the analysis.
An echocardiogram was performed at baseline and at 6 months in subjects with MPP activated. The outcome evaluated the percentage of change in LVESV, left ventricular end-diastolic volume (LVEDV), left ventricular end systolic diameter (LVESD), left ventricular end diastolic diameter (LVEDD), and left ventricular ejection fraction (LVEF) as compared to baseline prior to implant. The values of change with positive numbers represent increases and negative numbers represent decreases.
Outcome measures
| Measure |
MPP ON
n=74 Participants
MPP ON: Subjects implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
|
|---|---|
|
Changes in LV Echocardiographic Parameters
LVESV
|
-25.33 Percent change
Standard Deviation 31.42
|
|
Changes in LV Echocardiographic Parameters
LVEDV
|
-14.90 Percent change
Standard Deviation 28.09
|
|
Changes in LV Echocardiographic Parameters
LVESD
|
-10.72 Percent change
Standard Deviation 14.53
|
|
Changes in LV Echocardiographic Parameters
LVEDD
|
-7.23 Percent change
Standard Deviation 11.72
|
|
Changes in LV Echocardiographic Parameters
LVEF
|
9.37 Percent change
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 6 monthsThe outcome evaluated the number of CRT super-responders at 6 months in subjects with MPP activated. A super-responder is defined as a subject with a mean absolute LVEF increase of \>14% at 6 months post-implant compared to baseline.
Outcome measures
| Measure |
MPP ON
n=77 Participants
MPP ON: Subjects implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
|
|---|---|
|
Number of CRT Super-responders
|
27 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe outcome measures rates of all-cause mortality, all-cause hospitalization, cardiovascular hospitalization, and heart failure hospitalization. In addition, the outcome measures the combined endpoint of mortality and heart failure hospitalization and mortality and cardiovascular hospitalization. For the combined endpoints, if a participant experienced both endpoints, they were counted as one participant.
Outcome measures
| Measure |
MPP ON
n=105 Participants
MPP ON: Subjects implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
|
|---|---|
|
Rates of Hospitalization and Mortality
All-cause mortality
|
2 Participants
|
|
Rates of Hospitalization and Mortality
All-cause hospitalization
|
12 Participants
|
|
Rates of Hospitalization and Mortality
Heart failure hospitalization
|
1 Participants
|
|
Rates of Hospitalization and Mortality
Cardiovascular hospitalization
|
4 Participants
|
|
Rates of Hospitalization and Mortality
Combined mortality/heart failure hospitalization
|
2 Participants
|
|
Rates of Hospitalization and Mortality
Combined mortality/cardiovascular hospitalization
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Subjects implanted with a CRT-D device and a Quartet quadripolar LV lead, programmed with the MPP feature activated and who had a NYHA classification evaluation at baseline and 6 months.
The outcome measures status changes in NYHA classification at 6 months for subjects with MPP activated. Subjects experienced either an improvement, worsening, or no change in NYHA classification. The NYHA provides a simple way of classifying the extent of heart failure: NYHA I: No limitation of physical activity. Ordinary physical activity does not cause fatigue, palpitation, dyspnea. NYHA II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea. NYHA III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. NYHA IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest.
Outcome measures
| Measure |
MPP ON
n=82 Participants
MPP ON: Subjects implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
|
|---|---|
|
Change in NYHA Classification
Improvement in NYHA classification
|
26 Participants
|
|
Change in NYHA Classification
Worsening in NYHA classification
|
2 Participants
|
|
Change in NYHA Classification
NYHA classification unchanged
|
54 Participants
|
Adverse Events
Total Enrolled
Serious adverse events
| Measure |
Total Enrolled
n=105 participants at risk
All subjects enrolled in the study are included in the outcome measure.
|
|---|---|
|
Cardiac disorders
Atrial Arrhytmia
|
1.9%
2/105 • Number of events 3 • 6 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Nervous system disorders
Encephalopathy
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Exacerbation of Heart Failure
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Trauma
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Chest Pain
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Inappropriate shock
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Infection
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Lead dislodgment
|
3.8%
4/105 • Number of events 6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax/Hemothorax
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Subclavian Vein Thrombus
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Twiddler´s Syndrome
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.95%
1/105 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Total Enrolled
n=105 participants at risk
All subjects enrolled in the study are included in the outcome measure.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hematoma/Seratoma
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Inappropiate shock
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Intermittent pacing
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Lead dislodgement
|
3.8%
4/105 • Number of events 4 • 6 months
|
|
Cardiac disorders
Oversensing
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pectoral/Diaphragmatic/Phrenic Nerve Stimulation
|
1.9%
2/105 • Number of events 2 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place